Terminological Confusion About Sedation in Palliative Care: Results of an International Online Vignette Survey.

Background: Terminological problems concerning sedation in palliative care and consequences for research and clinical decision making have been reported frequently. Objectives: To gather data on the application of definitions of sedation practices in palliative care to clinical cases and to analyze implications for high-quality definitions. Design: We conducted an online survey with a convenience sample of international experts involved in the development of guidelines on sedation in palliative care and members of the European Association for Palliative Care (EAPC). Participants were asked to apply four published definitions to four case vignettes. Data were analyzed using descriptive statistics. Results: A total of 32 experts and 271 EAPC members completed the survey. The definitions were applied correctly in n = 2200/4848 cases (45.4%). The mean number of correct applications of the definitions (4 points max.) was 2.2 ± 1.14 for the definition of the SedPall study group, 1.8 ± 1.03 for the EAPC definition, 1.7 ± 0.98 for the definition of the Norwegian Medical Association, and 1.6 ± 1.01 for the definition of the Japanese Society of Palliative Medicine. The rate of correct applications for the 16 vignette-definition pairs varied between 70/303 (23.1%) and 227/303 (74.9%). The content of definitions and vignettes together with free-text comments explains participants' decisions and misunderstandings. Conclusions: Definitions of sedation in palliative care are frequently incorrectly applied to clinical case scenarios under simplified conditions. This suggests that clinical communication and research might be negatively influenced by misunderstandings and inconsistent labeling or reporting of data. Clinical Trial Registration Number: DRKS00015047.

What is an "early palliative care" intervention? A scoping review of controlled studies in oncology.

INTRODUCTION: Early palliative care (EPC) has been advocated to improve cancer patients' health. However, EPC differs with regard to its elements and target groups. It is not known which parts of EPC contribute to effectiveness for which patient group. This scoping review provides a structured analysis of EPC interventions and outcome measures. DESIGN: We searched EMBASE, MEDLINE, CINAHL, and CENTRAL up to February 2022. We included randomized controlled trials (RCT), nonrandomized trials, cohort studies (CS), and controlled before-after studies of EPC in adult patients in English, Dutch, and German language. Interventions had to be self-labeled as EPC. Screening and data extraction were performed by two raters. A structured analysis incorporating the TIDieR checklist was performed to describe the elements of the interventions. RESULTS: We screened 2651 articles, resulting in 40 articles being included: 34 studies were RCT and six studies were CS with a mean sample size of 208 patients. Patients with pancreatic (n = 10) and lung cancer (n = 9) were most often included. Studies reported different reference points for the onset of EPC such as time after diagnosis of incurable cancer (n = 18) or prognosis (n = 9). Thirteen studies provided information about elements of EPC and eight studies about the control intervention. Most frequent elements of EPC were symptom management (n = 28), case management (n = 16), and advance care planning (ACP; n = 15). Most frequently reported outcome measures were health-related quality of life (n = 26), symptom intensity (n = 6), resource use, and the patient's mood (n = 4 each). CONCLUSION: The elicited heterogeneity of ECP in combination with deficits of reporting are considerable barriers that should be addressed to further develop effective EPC interventions for different groups of cancer patients.

Expert-approved best practice recommendations on the use of sedative drugs and intentional sedation in specialist palliative care (SedPall).

BACKGROUND: The use of sedative drugs and intentional sedation in end-of-life care is associated with clinical, ethical and legal challenges. In view of these and of the issue's great importance to patients undergoing intolerable suffering, we conducted a project titled SedPall ("From anxiolysis to deep continuous sedation - Development of recommendations for sedation in palliative care") with the purpose of developing best practice recommendations on the use of sedative drugs and intentional sedation in specialist palliative care and obtaining feedback and approval from experts in this area. DESIGN: Our stepwise approach entailed drafting the recommendations, obtaining expert feedback, conducting a single-round Delphi study, and convening a consensus conference. As an interdisciplinary group, we created a set of best practice recommendations based on previously published guidance and empirical and normative analysis, and drawing on feedback from experts, including patient representatives and of public involvement participants. We set the required agreement rate for approval at the single-round Delphi and the consensus conference at ≥80%. RESULTS: Ten experts commented on the recommendations' first draft. The Delphi panel comprised 50 experts and patient and public involvement participants, while 46 participants attended the consensus conference. In total, the participants in these stages of the process approved 66 recommendations, covering the topics "indications", "intent/purpose [of sedation]", "decision-making", "information and consent", "medication and type of sedation", "monitoring", "management of fluids and nutrition", "continuing other measures", "support for relatives", and "team support". The recommendations include suggestions on terminology and comments on legal issues. CONCLUSION: Further research will be required for evaluating the feasibility of the recommendations' implementation and their effectiveness. The recommendations and the suggested terminology may serve as a resource for healthcare professionals in Germany on the use of sedative drugs and intentional sedation in specialist palliative care and may contribute to discussion on the topic at an international level. TRIAL REGISTRATION: DRKS00015047 (German Clinical Trials Register).

Documentation of Sedation in Palliative Care: A Scoping Review of Requirements, Recommendations, and Templates.

Objective: To identify and describe requirements, recommendations, and templates for the documentation of sedation in adult palliative care. Introduction: International literature shows inconsistency in clinical practice regarding sedation in palliative care accompanied by legal, ethical, and medical uncertainties. Documentation in general serves as proof for previous treatments. In the context of intentional sedation to relieve suffering at the end of life, documentation provides a clear demarcation against practices of euthanasia. Inclusion Criteria: Articles with full-text version published in English or German since 2000, covering documentation requirements, recommendations, monitoring parameters or templates for sedation in adult palliative care were included. Methods: Scoping review following the JBI methodology. Search in online databases, websites of professional associations in palliative care, reference lists of relevant publications, the archive of the German "Journal of Palliative Medicine" and databases for unpublished literature were used. Search terms included "palliative care,' "sedation," and "documentation." The search was conducted from January 2022 to April 2022 with an initial hand search in November 2021. Data were screened and charted by one reviewer after conducting a pilot test of the criteria. Results: From the initial 390 articles (database search), 22 articles were included. In addition, 15 articles were integrated from the hand search. The results can be clustered in two sets of items, regarding either the documentation before or during sedation. The documentation requirements referred both to inpatient and homecare settings but in many cases, a clear assignment was missing. Conclusions: The guidelines analyzed in this study rarely cover setting-specific differences in documentation and often treat documentation as minor topic. Further research is needed addressing legal and ethical concerns of health care teams and, therefore, help to improve treatment of patients suffering from otherwise intractable burden at the end of life.

The impact of the COVID-19 pandemic on processes, resource use and cost in palliative care.

BACKGROUND: The COVID-19 pandemic impacts on working routines and workload of palliative care (PC) teams but information is lacking how resource use and associated hospital costs for PC changed at patient-level during the pandemic. We aim to describe differences in patient characteristics, care processes and resource use in specialist PC (PC unit and PC advisory team) in a university hospital before and during the first pandemic year. METHODS: Retrospective, cross-sectional study using routine data of all patients cared for in a PC unit and a PC advisory team during 10-12/2019 and 10-12/2020. Data included patient characteristics (age, sex, cancer/non-cancer, symptom/problem burden using Integrated Palliative Care Outcome Scale (IPOS)), information on care episode, and labour time calculated in care minutes. Cost calculation with combined top-down bottom-up approach with hospital's cost data from 2019. Descriptive statistics and comparisons between groups using parametric and non-parametric tests. RESULTS: Inclusion of 55/76 patient episodes in 2019/2020 from the PC unit and 135/120 episodes from the PC advisory team, respectively. IPOS scores were lower in 2020 (PCU: 2.0 points; PC advisory team: 3.0 points). The number of completed assessments differed considerably between years (PCU: episode beginning 30.9%/54.0% in 2019/2020; PC advisory team: 47.4%/40.0%). Care episodes were by one day shorter in 2020 in the PC advisory team. Only slight non-significant differences were observed regarding total minutes/day and patient (PCU: 150.0/141.1 min., PC advisory team: 54.2/66.9 min.). Staff minutes showed a significant decrease in minutes spent in direct contact with relatives (PCU: 13.9/7.3 min/day in 2019/2020, PC advisory team: 5.0/3.5 min/day). Costs per patient/day decreased significantly in 2020 compared to 2019 on the PCU (1075 Euro/944 Euro for 2019/2020) and increased significantly for the PC advisory team (161 Euro/200 Euro for 2019/2020). Overhead costs accounted for more than two thirds of total costs. Direct patient cost differed only slightly (PCU: 134.7 Euro/131.1 Euro in 2019/2020, PC advisory team: 54.4 Euro/57.3 Euro). CONCLUSIONS: The pandemic partially impacted on daily work routines, especially on time spent with relatives and palliative care problem assessments. Care processes and quality of care might vary and have different outcomes during a crisis such as the COVID-19 pandemic. Direct costs per patient/day were comparable, regardless of the pandemic.

"It's pretty much flying blind in the home care setting": A qualitative study on the influence of home care specific circumstances on sedation in specialist palliative home care.

BACKGROUND: Existing data on sedation at the end of life indicate challenges in the home care setting, leading to deviations from guidelines or non-provision of sedation. AIM: As part of the "SedPall" study, we aimed to explore circumstances in specialist palliative home care, which influence the practice of sedation. DESIGN: Semi-structured qualitative interviews (n = 59) and two focus groups (n = 4, n = 5). Recruitment took place via contact persons. We thematically analyzed the transcripts with the Framework Approach, using MAXQDA 2018.2. SETTING/PARTICIPANTS: Physicians, nurses, and other members of the multiprofessional team from 10 palliative care units and seven home care teams. RESULTS: Participants reported home care specific circumstances that can be categorized into three interrelated topics. (1) Lack of 24/7 on-site availability, (2) active involvement of the family, (3) challenges regarding teamwork and multidisciplinarity. Participants drew different conclusions from the reported circumstances regarding the feasibility of different types of sedation at home: While some reported to generally use all types of sedation, others stated that some types of sedation are not feasible in home care, for example deep sedation until death. Most participants questioned the applicability of existing sedation guidelines in the home care setting. CONCLUSION: Our data indicate that sedation practices might currently follow the healthcare professional's attitude or service policy rather than the patient's need. To avoid hospital admission in manageable cases and ensure that home care specific best practice standards are met, existing guideline recommendations have to be adapted and supplemented by additional supporting measures specific for the home care setting.

Possible age-related differences in healthcare professionals' perspectives on younger and older patients' autonomy and decision-making in the context of sedation in specialised palliative care: exploratory secondary qualitative content and linguistic conversation analysis of interviews with healthcare professionals.

BACKGROUND: Chronic illnesses and multi-morbidity can threaten competence and independence, particularly in old age. Autonomy becomes increasingly important in the context of sedation, as in this case medication leads to (further) changes of consciousness. The study aimed to identify possible age-related differences in the perspectives of healthcare professionals on patients' autonomy, in the context of sedation in specialised palliative care. METHOD: Secondary analysis of interviews with healthcare professionals, analysed by qualitative content and linguistic conversation analysis. The interviews analysed span 51 healthcare professionals in specialised palliative care across 17 centres (adult inpatient and specialist palliative home care services) in Germany. RESULTS: The study shows that the perspectives of healthcare professionals on patients' autonomy differs according to the age of the patient in the context of sedation in specialised palliative care. The different perspectives may lead to different ways of treating the patients, for example a greater space of autonomy and decision-making for younger patients. CONCLUSION: In particular, measures that may restrict consciousness (e.g. sedation) and thus influence patients' ability to fully exercise their autonomy and fully participate in decision-making require special attention by healthcare professionals with respect to possible influences on treatment, such as different perceptions by healthcare professionals based on the patient's age or age-related stereotypes. TRIAL REGISTRATION: The study "SedPall" is registered in the German Clinical Trials Register (ID: DRKS00015047 ).

"Palliative Syringe Driver"? A Mixed-Methods Study in Different Hospital Departments on Continuous Infusions of Sedatives and/or Opioids in End-of-Life Care.

OBJECTIVES: Continuous infusions of sedatives and/or opioids (continuous infusions) are frequently used in end-of-life care. Available data indicate challenges in nonspecialist palliative care settings. We aimed to assess the use of continuous infusions during the last week of life in different hospital departments. METHODS: In a sequential mixed-methods design, a retrospective cohort study was followed by consecutive qualitative interviews in 5 German hospital departments. Medical records of 517 patients who died from January 2015 to December 2017 were used, and 25 interviews with physicians and nurses were conducted. Recorded sedatives were those recommended in guidelines for "palliative sedation": benzodiazepines, levomepromazine, haloperidol (≥5 mg/d), and propofol. Exploratory statistical analysis (R 3.6.1.) and framework analysis of interviews (MAXQDA 2018.2) were performed. RESULTS: During the last week of life, 359 of 517 deceased patients (69%) received continuous infusions. Some interviewees reported that continuous infusions are a kind of standard procedure for "palliative" patients. According to our interviewees' views, equating palliative care with continuous infusion therapy, insufficient experience regarding symptom control, and fewer care needs may contribute to this approach. In addition, interviewees reported that continuous infusions may be seen as an "overall-concept" for multiple symptoms. Medical record review demonstrated lack of a documented indication for 80 of 359 patients (22%). Some nurses experienced concerns or hesitations among physicians regarding the prescription of continuous infusions. CONCLUSIONS: Continuous infusions seem to be common practice. Lack of documented indications and concerns regarding the handling and perception of a "standard procedure" in these highly individual care situations emphasize the need for further exploration and support to ensure high quality of care.

Sedatives and Sedation at the End of Life in the Hospital.

BACKGROUND: Data on sedation at the end of life (eol) in different medical disciplines are scarce and mostly based on subjective reports. We aimed to assess the use of sedatives with continuous effect in the last week of life and associated factors in different hospital departments, with the aid of objectifiable criteria. METHODS: We conducted a retrospective cohort study based on the medical records of patients who died in one of five clinical departments of German hospitals between January 2015 and December 2017 (hematology/oncology [two different departments], neurology, geriatrics, and gynecology). The use of sedatives that are recommended in guidelines for palliative sedation was analyzed, irrespective of indication and treatment intent, with the aid of published definitions of continuous effect and of at least moderately sedating doses. The analysis consisted of descriptive statistics and multivariate logistic regression analysis. RESULTS: 260/517 (50%) of the patients who died were given sedatives with continuous effect in the last week of life, 53/517 (10%) in at least moderately sedating doses. For 76/260 (29%) patients, no indication was noted. The term "sedation" was used in the medical records of 20/260 (8%) patients. The use of sedatives with continuous effect was significantly associated with the department in which the patient was treated (hematology/oncology II: OR 0.32, 95% CI [0.16: 0.63]; geriatrics: OR 0.23, 95% CI [0.10:0.50]; reference, hematology/oncology I). CONCLUSION: It was not possible to draw a clear distinction between the use of sedatives for symptom control, without sedating effect or intent to sedate, and intentional sedation to relieve suffering. The observed differences between hospital departments and deviations from recommended practice, e.g. lack of documentation of the indication, warrant further exploration. Moreover, context-specific supportive measures for the use of sedatives and sedation at the end of life should be developed.

[Symptom Control at the End of Life]. / Symptomkontrolle am Lebensende.

Symptom Control at the End of Life Abstract. Patients with advanced disease suffer from multiple physical and psychological symptoms. These include pain, weakness, lack of energy, weight loss, breathlessness, nausea and vomiting, constipation, and depression. In the dying phase, death rattle, delirium and terminal agitation may be additional problems. Palliative care focusses on alleviating these symptoms, taking into account the physical, psychological, social and spiritual dimension. Main principles of symptom control in palliative care are 1) considering differential diagnoses of the causes of the symptom to be able to treat potentially reversible causes, 2) using preventive measures and 3) symptomatic treatment - on its own or in combination with causal therapy. The following should be noted regarding pharmacological treatment: In case of permanent symptoms, the drugs have to be given at fixed times, in accordance with their duration of action, to achieve a constant blood level. In addition to this regular drug administration, prn medication should be prescribed, e. g., for pain, breathlessness, and nausea. If oral administration is not possible, drugs can be administered intravenously, subcutaneously or transdermally via patches. Non-pharmacological measures can be used additionally or primarily for symptom control. This paper presents important aspects of symptom control for pain, breathlessness, nausea and vomiting, constipation, and depression as well as for symptoms in the dying phase. It concludes by adding a few words on sedation in palliative care as a measure of last resort.

Intentional Sedation as a Means to Ease Suffering: A Systematically Constructed Terminology for Sedation in Palliative Care.

Background: Terminology concerning sedation in palliative care is heterogeneous, vague, and difficult to apply with negative impact on the reliability of quantitative data, practice, and ethical discourse. Design: To clarify the concept, we systematically developed definitions of core terms in an interdisciplinary research group comprising palliative care, ethics, law, and philosophy, integrating feedback from external experts. Results: We define terms stepwise, separating matters of terminology (What is the practice?) from matters of good practice (How to use it?). We start with an operational definition of "reduced level of consciousness" (score < 0 on the Richmond Agitation-Sedation Scale modified for palliative care inpatients (RASS-PAL), followed by defining "sedating," "sedation," and "intentional sedation" as the result or process of sedating a patient as a means of achieving a previously defined treatment goal and the terms "light," "deep," "temporary," and "sedation until death." Conclusion: The terminology facilitates the precise phrasing of aims, indications, and rules for good practice. Empirical research on acceptance and feasibility is needed.

Sedatives and sedation at the end of life: a nursing home retrospective cohort study.

OBJECTIVES: Sedatives are frequently used at the end of life in specialist palliative care. There is scarce information about their use in nursing homes. Therefore, we aimed to assess the use of (1) sedatives generally and (2) 'sedatives with continuous effect', based on objective operational criteria, within the last week of life in a nursing home. METHODS: This was a retrospective cohort study of residents who died in a German nursing home between 1/2015 and 12/2017, using the nursing home's medical records, which contained drug sheets and nurses' notes. Sedatives analysed were those recommended by guidelines for 'palliative sedation': benzodiazepines, levomepromazine, haloperidol (≥5 mg/day) and propofol. Exploratory statistical analysis was conducted using R V.3.6.1. RESULTS: 46/165 (28%) deceased residents received a sedative during the last week of life, all without use of the term 'sedation'. 26/165 residents (16%) received 'sedatives with continuous effect', for median 4 days (range 1-7). Oral lorazepam was used most frequently, mainly for agitation, anxiety and dyspnoea, but also due to palliative status and patients wish. The median total daily dose of lorazepam within the last week of life was 1.5 mg (range 0.5-7.5). The term 'palliative' was significantly more often used for residents receiving sedatives (p=0.001). CONCLUSIONS: Compared with published data on continuous deep sedation, moderate or deep sedation was less frequent in this nursing home and never labelled as 'sedation'. Multicentre mixed-methods research is needed to gain representative and more detailed data on sedation practices at the end of life in nursing homes.

Challenges and Strategies Regarding Sedation at the End of Life in Hospitals and Nursing Homes.

CONTEXT: Sedation is an accepted, but controversially discussed and challenging measure to treat suffering at the end of life. Although most people die in hospitals or nursing homes, little is known how professionals in these settings deal with sedatives and sedation at the end of life. OBJECTIVES: To explore 1) challenges regarding use of sedatives and sedation at the end of life in hospitals and nursing homes, and 2) strategies, and supportive measures to meet these challenges, as perceived by nurses and physicians. METHODS: Multicenter qualitative interview study. Forty-nine participants: 12 general practitioners and 12 nurses from five nursing homes, 12 physicians, and 13 nurses from five hospital departments (hematology/oncology (n = 2), neurology, geriatrics, gynecology). Semi-structured qualitative interviews. Data analysis guided by framework approach. RESULTS: Perceived challenges relate to three levels of the care situation: individual, interaction with others, and work environment. The main challenge was defining the adequate timing and/or dose. Other challenges, e.g., disagreements regarding indication or legal uncertainties, were highly interrelated, and strongly associated with this major challenge. Reported strategies and supportive measures to address challenges also corresponded to the three interrelated levels. Major named strategies were education and training, joint decision-making within the team and regular discussion with the patient and family. On the level work environment, no implemented strategies, but wishes for change were identified. CONCLUSION: To meet the identified challenges in a sustainable way and enable continuous improvement of quality of care, best practice recommendations, and other supportive measures have to address all identified levels of challenges.

"We don't want to sedate him" - A qualitative interview study on intentions when administering sedative drugs at the end of life in nursing homes and hospitals.

BACKGROUND: Previous data indicate major differences between countries and settings regarding the intention when administering sedative drugs at the end of life and the perception, which drugs are sedating. Therefore, we aimed to explore the concept of 'sedative drugs' and the intentions of German healthcare professionals in general palliative care when administering sedative drugs at the end of life. METHODS: Semi-structured qualitative interviews with physicians and nurses (n = 49). Recruitment took place via contact persons in five hospital departments (haematology/oncology (n = 2), neurology, geriatrics, gynaecology) and five nursing homes. We thematically analysed the transcripts by the Framework approach, using MAXQDA version 2018.2. RESULTS: Most interviewees referred to benzodiazepines, opioids, and antipsychotics. Some subsumed all into sedative drugs, others differentiated between sedative drugs, anxiolytics, and analgesics. In explaining their intention, interviewees particularly emphasized what they want to avoid when administering sedative drugs. We identified three main themes regarding (excluded) intentions: (1) use of sedative drugs to relieve the patient's suffering with reduction of consciousness as side effect, (2) use of sedative drugs to relieve the situation for the team and/or the family, (3) distinction between intention and expectation regarding hastening death. Interviewees often equated the term 'sedation' with inducing a state of unconsciousness, which should be avoided. CONCLUSION: German healthcare professionals in general palliative care seem to negatively connote the term 'sedation'. Moreover, they see themselves in a more passive role by accepting a side effect rather than performing an intentional act. Critical reflection of indications and intentions in accordance with respective guidelines is needed.

[Sedation in palliative care - step by step]. / Sedierung in der Palliativversorgung ­ Schritt für Schritt.

Sedation in palliative care, also called "palliative sedation", is an important treatment option for patients who experience unbearable suffering from treatment-refractory symptoms at the end of life. The aim is to reduce this suffering as far as possible by reduction of the patient's consciousness. Good communication between all people involved is crucial for these clinically and ethically challenging situations. This article presents definitions of key terms and of different types of sedation. It then describes the process of sedation step by step: 0. Pre-emptive discussion of the option of sedation (in the context of advance care planning); 1. indication and decision making; 2. information and informed consent; 3. documentation when starting sedation; 4. start of sedation; 5. monitoring and adaption of sedation; 6. medical and nursing care and documentation during sedation; 7. care and processes after the death of the patient (if applicable).

Sedatives and Sedation at the End of Life in Nursing Homes: A Retrospective Multicenter Cohort Study.

OBJECTIVES: There is scarce information about sedation in nursing homes at the end of life. We aimed to assess (1) the use of sedatives generally and "sedatives with continuous effect," based on objective operational criteria, within the last week of life in nursing homes and (2) factors associated with this treatment. DESIGN: Retrospective cohort study, using the nursing homes' medical records. SETTING AND PARTICIPANTS: Residents who died in 4 German nursing homes from January 2015 to December 2017 and whose medical records were available (n = 512). METHODS: Sedatives analyzed were those recommended by guidelines for "palliative sedation": benzodiazepines, levomepromazine, haloperidol (≥5 mg/d), and propofol. The definition of "sedatives with continuous effect" and doses judged as at least moderately sedating were consented by palliative care clinicians and pharmacists, based on the literature. Descriptive statistics and multivariate logistic regression analysis were performed (R version 3.6.1). RESULTS: Overall, 110/512 (21%) deceased residents received a sedative at least once during the last week of life, 46/512 (9%) "sedatives with continuous effect." Oral lorazepam was used most frequently. Eleven of 512 (2%) residents received doses judged as at least moderately sedating. The term sedation was not used. Most frequent indications were agitation (58/110; 53%) and anxiety (35/110; 32%); no indication was noted for 36/110 (33%) residents. The resident's involvement in the decision for sedatives was documented in 3/110 (3%). Multivariate logistic regression analysis showed significant associations between use of sedatives and age (OR = 0.94, P < .001) as well as institution (P < .001). CONCLUSIONS AND IMPLICATIONS: Our data indicate a lower prevalence of sedation compared to international data and considerable differences regarding prevalence between institutions. These differences, potential setting-specific challenges, and need for support measures for consistent best practice of sedation in nursing homes should be further explored.

[Patient and public involvement (PPI) in palliative care research]. / Patient*innen gestalten Forschung in der Palliativmedizin mit.

BACKGROUND: Patient and public participation in health research is of increasing social importance. The participation of citizens (patients, their next or interested parties) is not yet structurally anchored in Germany. This manuscript aims to present and to discuss first experiences with patient and public involvement in two palliative care centers. METHODS: In two centers, a general patient and public involvement committee (Erlangen) and a project-associated patient and public involvement group (Munich) were founded. Strategies for recruitment of potential members (public lectures, personal contact, information on the website, leaflets) were developed and applied. Sociodemographic data and motivations were assessed using survey and personal communication. 18 months after foundation citizens were asked to give feedback on participation during personal meetings. RESULTS: The 20 members of the PPI committee (14 female) are between 52 and 86 years old in Erlangen. The PPI group in Munich has 7 members (5 female). Motivations to contribute are, for example, gratefulness for the care of a relative or the wish to share occupational competencies for a good purpose. Voluntary participation took place by consulting the research teams. Consultation was, among others, performed in joint sessions with brainstorming, moderated group discussions, piloting and commenting interview guides, texts or website content. Participation improved the quality of study material and data assessment instruments. Citizens appreciated that they were able to gain new information and meet people from different fields. They partly wished there was a more detailed preparation and debriefing after joint meetings. The research teams did not quantify the considerable staff and time expenses. DISCUSSION: The recruitment strategies used have proved successful, and the experiences so far indicate a positive impact of PPI on research in the field of palliative care. Research is needed to evaluate the resources required and the effect of PPI in palliative care. On a structural level, discussion of PPI as one specification of voluntary engagement in palliative care, centralized provision of general information on PPI in palliative care and the possibilities of exchange between PPI groups and researchers of different facilities, should take place. CONCLUSION: There is a need for networking and exchange among researchers and citizens of different project groups with experience in PPI. An institutionalized provision of expertise would pave the way for PPI in palliative research.

A brief, patient- and proxy-reported outcome measure in advanced illness: Validity, reliability and responsiveness of the Integrated Palliative care Outcome Scale (IPOS).

BACKGROUND: Few measures capture the complex symptoms and concerns of those receiving palliative care. AIM: To validate the Integrated Palliative care Outcome Scale, a measure underpinned by extensive psychometric development, by evaluating its validity, reliability and responsiveness to change. DESIGN: Concurrent, cross-cultural validation study of the Integrated Palliative care Outcome Scale - both (1) patient self-report and (2) staff proxy-report versions. We tested construct validity (factor analysis, known-group comparisons, and correlational analysis), reliability (internal consistency, agreement, and test-retest reliability), and responsiveness (through longitudinal evaluation of change). SETTING/PARTICIPANTS: In all, 376 adults receiving palliative care, and 161 clinicians, from a range of settings in the United Kingdom and Germany. RESULTS: We confirm a three-factor structure (Physical Symptoms, Emotional Symptoms and Communication/Practical Issues). Integrated Palliative care Outcome Scale shows strong ability to distinguish between clinically relevant groups; total Integrated Palliative care Outcome Scale and Integrated Palliative care Outcome Scale subscale scores were higher - reflecting more problems - in those patients with 'unstable' or 'deteriorating' versus 'stable' Phase of Illness (F = 15.1, p < 0.001). Good convergent and discriminant validity to hypothesised items and subscales of the Edmonton Symptom Assessment System and Functional Assessment of Cancer Therapy-General is demonstrated. The Integrated Palliative care Outcome Scale shows good internal consistency (α = 0.77) and acceptable to good test-retest reliability (60% of items kw > 0.60). Longitudinal validity in form of responsiveness to change is good. CONCLUSION: The Integrated Palliative care Outcome Scale is a valid and reliable outcome measure, both in patient self-report and staff proxy-report versions. It can assess and monitor symptoms and concerns in advanced illness, determine the impact of healthcare interventions, and demonstrate quality of care. This represents a major step forward internationally for palliative care outcome measurement.